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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 14 GA X 6" (16 CM); CATHETER PERCUTANEOUS
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ARROW INTERNATIONAL LLC ARROW CVC SET: 14 GA X 6" (16 CM); CATHETER PERCUTANEOUS Back to Search Results
Catalog Number ES-04706
Device Problems Unsealed Device Packaging (1444); Material Puncture/Hole (1504)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/13/2023
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It is reported that: a small hole was found in the packaging which resulted in the device not being sterile.It was identified prior to use.There was no patient involvement.It was decided that the complaint was reportable after investigation of the returned device.
 
Manufacturer Narrative
(b)(4).The customer returned one, unopened cvc kit for analysis.The seal along the outer edge of the lidstock was intact and uniform along the tray.Visual analysis revealed that the kit lidstock and tray contained a sterility breach in the form of a small hole.Microscopic examination confirmed the hole on both the lidstock and the tray.Both were observed to be in the top-right corner of the tray.It is being assumed that the damage to the lidstock also caused the damage to the tray.The packaging facility was contacted as part of this complaint investigation.They confirmed that the damage likely occurred after the kit was sealed; however, there are no process steps in the packaging process that typically result in the damage observed.The distribution centers (edc rhenus and ap07) were also contacted as part of this complaint investigation.In edc rhenus, they confirmed that this finished good shows no record of repackaging.Likewise, there is no record of this finished good showing such damage during their handling.In ap07, they confirmed that chinese labels are placed on the lidstocks of the kits; however, there is no process that can cause this type of damage.A dev ice history record review was performed, and no relevant findings were identified.The ifu provided with the kit informs the user, "do not use if package is damaged".The report of a sterility breach was confirmed through complaint investigation of the returned sample.Visual analysis revealed that the kit lidstock and tray contained a sterility breach in the form of two small holes.Based on the comments from the packaging facility and the distribution centers for this finished good, this type of damage has not been observed as part of the normal packaging/handling process.Additionally, there are inspections in place to check for such damage.Based on the customer report, the sample received, and the comments from packaging/distribution, storage/shipping likely caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.
 
Event Description
It is reported that: a small hole was found in the packaging which resulted in the device not being sterile.It was identified prior to use.There was no patient involvement.It was decided that the complaint was reportable after investigation of the returned device.
 
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Brand Name
ARROW CVC SET: 14 GA X 6" (16 CM)
Type of Device
CATHETER PERCUTANEOUS
Manufacturer (Section D)
ARROW INTERNATIONAL LLC
morrisville NC
Manufacturer (Section G)
ARROW INTERNATIONAL CR, A.S.
jamska 2359/47
zdar nad sazavou 591 0 1
EZ   591 01
Manufacturer Contact
katharine tarpley
3015 carrington mill blvd
morrisville, NC 27560
MDR Report Key18072812
MDR Text Key327395025
Report Number3006425876-2023-01133
Device Sequence Number1
Product Code DQY
UDI-Device Identifier00801902108418
UDI-Public00801902108418
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K862056
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility,Company Representative,Distributor
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 10/31/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/06/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Catalogue NumberES-04706
Device Lot Number71F22F1708
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/30/2023
Is the Reporter a Health Professional? No
Date Manufacturer Received12/04/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/09/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
NOT REPORTED; NOT REPORTED
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